25 Jan Variations Guideline for Human and Veterinary Medicines
Posted at 10:04h
in
This document provides recommendations for applicants submitting variation applications for human and veterinary medicines. In addition to this guideline, the South African Health Products Regulatory Authority (SAHPRA) reserves the right to request additional information to establish the safety, quality and efficacy of a medicine based the knowledge available at the time of evaluation. SAHPRA is committed to ensuring that all registered medicines meet the required quality, safety and efficacy.
Download latest version
Document Number:
SAHPGL-HPA-06
Version:
7
Date Updated:
09/06/2026
File Type:
www
Category:
Guideline